January 2012
NATIONAL INDUSTRIAL CHEMICALS NOTIFICATION AND ASSESSMENT SCHEME
(NICNAS)
PUBLIC REPORT
Additiv 309This Assessment has been compiled in accordance with the provisions of the Industrial Chemicals (Notification and Assessment) Act 1989 (Cwlth) (the Act) and Regulations. This legislation is an Act of the Commonwealth of Australia. The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) is administered by the Department of Health and Ageing, and conducts the risk assessment for public health and occupational health and safety. The assessment of environmental risk is conducted by the Department of Sustainability, Environment, Water, Population and Communities.
For the purposes of subsection 78(1) of the Act, this Public Report may be inspected at our NICNAS office by appointment only at Level 7, 260 Elizabeth Street, Surry Hills NSW 2010.
This Public Report is also available for viewing and downloading from the NICNAS website or available on request, free of charge, by contacting NICNAS. For requests and enquiries please contact the NICNAS Administration Coordinator at:
Street Address: Level 7, 260 Elizabeth Street, SURRY HILLS NSW 2010, AUSTRALIA.
Postal Address: GPO Box 58, SYDNEY NSW 2001, AUSTRALIA.
TEL: + 61 2 8577 8800
FAX + 61 2 8577 8888
Website: www.nicnas.gov.au
Director
NICNAS
TABLE OF CONTENTS
SUMMARY 3
CONCLUSIONS AND REGULATORY OBLIGATIONS 3
ASSESSMENT DETAILS 5
1. APPLICANT AND NOTIFICATION DETAILS 5
2. IDENTITY OF CHEMICAL 5
3. COMPOSITION 5
4. PHYSICAL AND CHEMICAL PROPERTIES 6
5. INTRODUCTION AND USE INFORMATION 6
6. HUMAN HEALTH IMPLICATIONS 7
7. ENVIRONMENTAL IMPLICATIONS 8
Appendix A: Physical and Chemical Properties 11
Appendix B: Toxicological Investigations 13
Appendix C: Environmental Fate and Ecotoxicological Investigations 14
BIBLIOGRAPHY 16
January 2012 NICNAS
SUMMARY
The following details will be published in the NICNAS Chemical Gazette:
ASSESSMENT REFERENCE / APPLICANT(S) / CHEMICAL OR TRADE NAME / HAZARDOUS SUBSTANCE / INTRODUCTION VOLUME / USELTD/1508 / BP Australia Pty Ltd / Amides from N1-(9Z)-9-octadecenyl-1,3-propanediamine and tall oil / ND* / ≤1000 kg / Anti-corrosion and lubricant additive in grease formulations for use in the mining, steel and printing industries
*ND = not determined
CONCLUSIONS AND REGULATORY OBLIGATIONS
Hazard classification
Based on the available data the notified chemical cannot be classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).
The classification of the notified chemical using the Globally Harmonised System for the Classification and Labelling of Chemicals (GHS) (United Nations 2009) is presented below.
Hazard category / Hazard statementAquatic environment / Acute Category 3
Chronic Category 3 / Harmful to aquatic life
Harmful to aquatic life with long lasting effects
Human health risk assessment
Under the conditions of the occupational settings described, the notified chemical is not considered to pose an unreasonable risk to the health of workers.
When used in the proposed manner, the notified chemical is not considered to pose an unreasonable risk to public health.
Environmental risk assessment
On the basis of the reported use pattern, the notified chemical is not considered to pose a risk to the environment.
Recommendations
Control Measures
Occupational Health and Safety
· Employers should implement the following safe work practices to minimise occupational exposure during handling of the notified chemical:
- Avoid contact with skin and eyes
- Do not inhale vapours/mists
- Avoid contact with uncured coatings or overspray
· Employers should ensure that the following personal protective equipment is used by workers to minimise occupational exposure to the notified chemical:
- Respirators
- Coveralls
- Gloves
- Goggles
Guidance in selection of personal protective equipment can be obtained from Australian, Australian/New Zealand or other approved standards.
· Where not already contained in the MSDS for products containing the notified chemical, appropriate engineering controls, safe work practices and personal protective equipment to reduce exposure should
be recommended on the product MSDS.
· A copy of the MSDS should be easily accessible to employees.
· If products and mixtures containing the notified chemical are classified as hazardous to health in accordance with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(2004)] workplace practices and control procedures consistent with provisions of State and Territory hazardous substances legislation must be in operation.
Disposal
· The notified chemical should be disposed of to landfill.
Emergency procedures
· Spills or accidental release of the notified chemical should be handled by physical containment, collection and subsequent safe disposal.
Regulatory Obligations
Secondary Notification
This risk assessment is based on the information available at the time of notification. The Director may call for the reassessment of the chemical under secondary notification provisions based on changes in certain circumstances. Under Section 64 of the Industrial Chemicals (Notification and Assessment) Act (1989) the notifier, as well as any other importer or manufacturer of the notified chemical, have post-assessment regulatory obligations to notify NICNAS when any of these circumstances change. These obligations apply even when the notified chemical is listed on the Australian Inventory of Chemical Substances (AICS).
Therefore, the Director of NICNAS must be notified in writing within 28 days by the notifier, other importer or manufacturer:
(1) Under Section 64(1) of the Act; if
- the importation volume exceeds one tonne per annum notified chemical;
- the function or use of the chemical has changed from a component of grease formulations at up to 4%.
or
(2) Under Section 64(2) of the Act; if
- the function or use of the chemical has changed from a component of grease formulations for industrial use, or is likely to change significantly;
- the chemical has begun to be manufactured in Australia;
- additional information has become available to the person as to an adverse effect of the chemical on occupational health and safety, public health, or the environment.
Material Safety Data Sheet
The MSDS of the notified chemical and products containing the notified chemical provided by the notifier were reviewed by NICNAS. The accuracy of the information on the MSDS remains the responsibility of the applicant.
ASSESSMENT DETAILS
This notification has been conducted under the cooperative arrangement with the United States Environmental Protection Agency (US EPA). Information pertaining to the assessment of the notified chemical by the US EPA was provided to NICNAS and, where appropriate, used in this assessment report. The other elements of the risk assessment, including the recommendations on safe use of the notified chemical, were carried out by NICNAS.
1. APPLICANT AND NOTIFICATION DETAILS
Applicant(s)BP Australia Pty Ltd (ABN 53 004 085 616)
132 McCredie Rd
Guildford NSW 2161
Notification Category
Limited-small volume: Chemical other than polymer (1 tonne or less per year).
Exempt Information (Section 75 of the Act)
Data items and details claimed exempt from publication: molecular and structural formulae, molecular weight, analytical data and import volume,
Variation of Data Requirements (Section 24 of the Act)
Variation to the schedule of data requirements is claimed as follows: water solubility, hydrolysis as a function of pH, adsorption/desorption, dissociation constant, partition coefficient and flammability.
Previous Notification in Australia by Applicant(s)
None
Notification in Other Countries
US EPA PMN: P-04-297
2. IDENTITY OF CHEMICAL
Marketing Name(s)Optimol Paste White T (imported product containing 3.6% notified chemical)
Optimol Paste White T Spray (imported product containing 1.7% notified chemical)
CAS Number
628723-38-6
Chemical Name
Amides from N1-(9Z)-9-octadecenyl-1,3-propanediamine and tall oil
Other Name(s)
Optimol Additiv 309 (>90% notified chemical)
Additiv 309 (>90% notified chemical)
Fatty amide derivative (generic name on MSDS)
Molecular Weight
>500 Da.
Analytical Data
Reference IR spectrum was provided.
3. COMPOSITION
Degree of Purity / >90%Hazardous Impurities/Residual Monomers
Chemical Name / 1,3-propanediamine N1-(9Z)-9-octadecen-1-yl
CAS No. / 7173-62-8 / Weight % / ≤ 5%
Hazardous Properties / R22, R34, R48/25
Chemical Name / Tall Oil
CAS No. / 8002-26-4 / Weight % / ≤ 5%
Hazardous Properties / R43
Non Hazardous Impurities/Residual Monomers (>1% by weight) / None
Additives/Adjuvants / None
4. PHYSICAL AND CHEMICAL PROPERTIES
Appearance at 20 ºC and 101.3 kPa: Brown liquidProperty / Value / Data Source/Justification
Melting Point/Freezing Point / -17 ±3 oC / Measured
Boiling Point / >400oC at 101.04 kPa / Measured
Density / 922 kg/m3 at 20±0.5oC / Measured
Vapour Pressure / 7.7 x10-6 kPa at 25 oC / Measured
Water Solubility / ≤2.4 × 10-13 g/L at 25oC / Estimated using WSKOWWIN v1.41a (USEPA 2008)
Hydrolysis as a Function of pH / Not Determined / Expected to be hydrolytically stable in environmental pH range (4-9)
Partition Coefficient
(n-octanol/water) / log Pow ≥ 13.5 / Estimated using KOWWIN v1.67a (US EPA 2008)
Adsorption/Desorption / Log Koc ≥ 10.0 (MCl Method)
Log Koc ≥ 8.3 (Kow Method) / Estimated using KOCWIN v2.00 from MCI and Kow (US EPA 2008)
Dissociation Constant / pKa ~ 9 – 10 / Estimated from analogous compounds
Particle Size / Not determined / Liquid
Flash Point / 300 oC / Measured
Flammability / Not highly flammable / Based on measured flash point
Autoignition Temperature / 370 ±5oC / Measured
Explosive Properties / Predicted negative / Based on chemical structure
Oxidising Properties / Predicted negative / Based on chemical structure
Discussion of Properties
For full details of tests on physical and chemical properties, refer to Appendix A.
Reactivity
The notified chemical is stable under normal conditions of use in air and water.
Dangerous Goods classification
Based on the submitted physical-chemical data in the above table the notified chemical is not classified according to the Australian Dangerous Goods Code (NTC, 2007). However, the data above do not address all Dangerous Goods endpoints. Therefore, consideration of all endpoints should be undertaken before a final decision on the Dangerous Goods classification is made by the introducer of the chemical.
5. INTRODUCTION AND USE INFORMATION
Mode of Introduction of Notified Chemical (100%) Over Next 5 YearsThe notified chemical will not be manufactured in Australia, but will be imported as a component in finished lubricant grease or spray. It will be present in grease product formulation (product name: Optimol Paste White T) at 3.6% and in the spray product formulation at 1.7% (product name: Optimol Paste White T Spray).
Maximum Introduction Volume of Notified Chemical (100%) Over Next 5 Years
Year / 1 / 2 / 3 / 4 / 5
Tonnes / 1 / 1 / 1 / 1 / 1
Port of Entry
Sydney
Transportation and Packaging
The notified chemical will be imported as a component of finished product formulations in 400 mL (spray), 500g and 5 kg containers and transported by road to end user sites.
Use
The notified chemical will be used as an anti-corrosion and lubricant additive in grease formulations for use in the mining, steel and printing industries. The notified chemical will be present in finished products at <4%.
Anti-fretting greases will be used to lubricate press-fitted parts, and allow disassembly when required.
The spray formulation containing the notified chemical will be used on printing press frames, to prevent printing ink adhering to the frames.
Operation description
The imported finished products containing the notified chemical at 4% will be distributed only to industrial customers and will only be used on equipment onsite.
For anti-fretting applications the grease product containing the notified chemical will be applied to equipment using a grease gun or lint-free cloth.
In printing press applications, the product will be sprayed onto the printing press frame and any excess will be wiped off with a lint-free cloth.
6. HUMAN HEALTH IMPLICATIONS
6.1. Exposure Assessment
6.1.1. Occupational Exposure
Category of Worker / Exposure Duration (hours/day) / Exposure Frequency (days/year)Import/dock/warehouse workers / 1-2 / 50-100
Pack drivers / 2-4 / 50-100
End users (mining, steel and printing) / 2-5 / 150-200
Exposure Details
Dermal and ocular exposure to the notified chemical at concentrations of <4% in grease products could occur during application and in case of a spill. However, workers in the mining, steel and printing industry are expected to use personal protective equipment (PPE) including gloves, safety goggles and coveralls to minimise the potential for dermal and ocular exposure.
Inhalation exposure is expected during application of the notified chemical in spray products. Product labels and MSDS for products containing the notified chemical advise the use of ventilation and respiratory protection to prevent exposure to other components of the product with occupational exposure limits. Inhalation exposure would be minimised when ventilation and respiratory protection are used.
6.1.2. Public Exposure
The grease products containing the notified chemical and the equipment to which they are applied are not intended for use by the general public. Therefore, the potential for public exposure to the notified chemical is unlikely.6.2. Human Health Effects Assessment
Based on the molecular weight (>500 Da.), estimated low water solubility (≤2.4x10-10 mg/L) and estimated high partition coefficient (≥13.5) of the notified chemical, the potential of the notified chemical to cross the gastrointestinal (GI) tract by passive diffusion or to be absorbed dermally or by inhalation is limited.An acute oral toxicity (fixed dose method) study was conducted on the notified chemical in rats which determined the LD50 > 2000 mg/kg bw (Harlan Laboratories, 2010). There were no mortalities or systemic effects reported in the study.
The notified chemical contains functional groups (secondary amines) that are associated with burns and irritation (Hulzebos et al., 2005). The notified chemical has been classified by the notifier with R41 Risk of serious eye damage and R38 Irritating to skin.
In addition, the notified chemical contains a hazardous residual monomer/impurity (tall oil) at a concentration up to 5%, which may result in sensitisation by skin contact.
Health hazard classification
Based on the available data the notified chemical cannot be classified as hazardous according to the Approved Criteria for Classifying Hazardous Substances (NOHSC, 2004).